510(k) K103313
K103313 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "HEPARIN ASSAY CONTROLS". The FDA issued a decision of Substantially Equivalent on December 1, 2010. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2010
- Date Received
- November 10, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasma, Coagulation Control
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type